Module 16 2024

10/17/2024

Why was an extension timeline needed?

The resources of qualified NBs in 2022 was not sufficient to transfer all existing medical device certificates into the MDR during the initial transition timeline.

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

7

7

Major Obstacles and Business Risks

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

8

8

4